Wound irrigation device and method

ABSTRACT

A method for irrigation of a wound, said method comprising a reservoir housing containing a wound irrigation solution and a discharge means attachable thereto, said discharge means having at least one port therethrough wherein said port, or ports forms a nozzle for directing a pressurized dispersed stream of said solution.

CROSS-REFERENCE TO A RELATED APPLICATION

This application is a continuation of application Ser. No. 08/824,999,filed Mar. 26, 1997, now U.S. Pat. No. 5,830,197 which is a continuationof application Ser. No. 08/464,034, filed on Jun. 5, 1995 now abandoned,which is a continuation of application Ser. No. 08/259,416, filed Jun.14, 1994, now abandoned.

BACKGROUND OF THE INVENTION

In the management and treatment of a wound (defined herein to mean anyinjury or opening in tissue) there are three primary objectives: (1)prevention of infection, (2) preservation and/or restoration offunction, and (3) preservation and/or restoration of cosmeticappearance. The most important of these objectives is the prevention ofinfection. Success in the prevention of infection directly affects thehealing process and the degree to which the other two objectives,function and cosmetic appearance, can be preserved and/or restored.

In the case of wounds, the presence of bacteria is the single cause ofinfection. It is known that the number of bacteria, rather thanbacterial type, is a critical determinant of whether a wound becomesinfected. Experimental evidence suggests that a critical level ofbacteria is approximately 10⁵ organisms per gram of tissue. Below thislevel, wounds heal; at levels greater than 10⁵ bacteria per gram oftissue, wounds often become infected. All traumatic wounds arecontaminated by the time the wound is presented to a medical carefacility for treatment (Dire, Daniel I. [1990] “A comparison of WoundIrrigation Solutions Used in the Emergency Department,” Annals ofEmergency Medicine 19(6):704-708). Dirty wounds, or those which have notbeen treated within six hours, are likely to be contaminated withbacteria at levels which are higher than the critical level. Reducingthe number of bacteria in and around the wound is a recognized andaccepted means for avoiding infection and expediting wound healing.

Different procedures of wound management have been developed to helpdecrease the level of bacteria present in a wound, i.e., reduce theincidence of infection. The cleansing of a wound and the sitesurrounding the wound to remove blood clots, debris, dirt, or otherforeign materials which can introduce contaminants, including pathogenicmicroorganisms, is critical in reducing levels of bacteria in and aroundthe wound. There are numerous wound cleansing procedures presently usedby healthcare professionals such as debridement, excision andirrigation. See, for example, Sinkinson, Craig Alan, ed. (1989)“Maximizing A Wound's Potential For Healing,” Emergency Medicine Reports10(11):83-89; Lammers, Richard L. (1991) “Soft Tissue Procedures:Principles of Wound Management,” in Clinical Procedures in EmergencyMedicine, Roberts and Hedges, eds., 2nd Ed., W. B. Saunders Company, pp.515-521; Cracroft, Davis (1987) “Minor Lacerations and Abrasions,”Emergency Medicine: A Comprehensive Review, Kravis and Warner, eds., 2ndcd., Aspen Publishing Co., pp. 107-110; and Mulliken, John B. (1984)“Management of Wounds,” in Emergency Medicine, May ed., John Wiley &Sons, pp. 283-286.

Irrigation is the most commonly used procedure for cleansing of opencontaminated wounds.

Irrigation involves the application of sterile solutions or fluids towounds to remove loose devitalized tissue, bacterial inoculum, bloodclots, loose debris, and foreign bodies proximate to and within thedepths of the wound. The two critical components of any effective woundirrigation method and/or device are: (1) the application of an adequatevolume of sterile irrigation solution to the wound, and (2) the use ofsufficient pressure applied in an effective dispersal pattern in thedelivery of the solution to effectively remove contaminants. Regardingvolume, the amount of irrigation solution required will depend upon thetype of wound and the level of contamination. Injuries which canintroduce a high amount of bacteria into a wound (such as puncturewounds and bites) may require 1 liter or more of irrigation solution.See Mulliken, 1989. Regarding pressure, it has been demonstrated thatstream pressure of a minimum of 7 pounds per square inch (psi) isrequired to effectively flush or remove contaminants from a wound.Irrigation pressure in excess of desired limits (e.g., 25 psi orgreater) may actually drive bacteria and particulate matter deeper intothe wound and thereby defeat the purpose of the irrigation process.High-pressure irrigation may also cause damage to healthy tissue andimpede the tissue's defenses and retard healing. Thus, effective woundirrigation requires the use and application of adequate volumes ofirrigation solution delivered to the wound in an effective dispersalpattern at appropriate pressures.

Bulb syringes or gravity flow irrigation devices deliver fluid at lowpressures and as such are ineffective in ridding wounds of smallparticulate matter or in sufficiently reducing wound bacterial counts.Irrigation by bulb syringe exerts a pressure of about 0.05 psi, whichdoes not reduce the number of bacteria or particulate contaminantsenough to prevent infection. The flow rate of irrigation fluid deliveredthrough intravenous (IV) tubing can be enhanced by inflation of a bloodpressure cuff around a collapsible plastic IV bag. This method iscumbersome and provides considerably less irrigation pressure than canbe delivered by a plunger-type syringe.

The plunger-type syringe is the most common irrigation device currentlyused. Its use involves filling the barrel of the syringe with sterileirrigation solution and depressing the plunger to generate and apply asingle pressurized stream of solution in and around the wound todislodge and rinse away contaminants. This device has two notabledisadvantages: (1) an extremely limited reservoir of irrigation fluid(typically a syringe with a 35 cc-capacity barrel), and (2) it islimited to dispersal and application of a single concentrated stream ofsolution to the wound. Consequently, in most cases, the syringe must berepeatedly refilled in order to apply sufficient quantities ofirrigation solution to a wound. This is time-consuming and cumbersome todo while attempting to maintain a sterile field. In an attempt toaddress this limitation, a device has been developed that involves asystem consisting of a syringe and IV tubing with a valve system thatattaches to a bottle of saline to provide a ready means of refilling thesyringe barrel. (Travenol pressure irrigation set, code no. 2D2113, orirriget, Ackrad Laboratories, Garwood, N.J.). Additionally, U.S. Pat.No. 4,357,937 describes a disposable, manually operable medicalirrigation device which is adapted for providing selective volume andstream intensity in liquid flow from a plurality of syringes. Thesedevices do not adequately address the disadvantages of using syringesfor irrigation as discussed above and are not commonly used in clinicalpractice due to their complexity of use and cost.

The amount of hydraulic pressure that can be delivered with aplunger-type syringe varies with the force exerted on the plunger of thesyringe and with the internal diameter of the attached needle.Plunger-type syringe devices that deliver moderate pressure employeither a 19 gauge needle attached to a 35 cc syringe, which createshydraulic pressure in the range of 7-8 psi, or a 30 ml syringe fittedwith a 19 gauge needle which typically creates about 7 psi irrigationpressure. A 22 gauge needle attached to a 12 cc syringe, delivers apressure of about 13 psi. Such pressures have been proven effective inwound irrigation, but, as stated above, such devices apply only a singlestream of solution to the wound. In addition, these described deviceshold less than adequate volumes of irrigation solution and thereforerequire repeated refilling which is time consuming and cumbersome.

U.S. Pat. No. 5,071,104 describes a wound irrigation apparatus andprocess for cleansing wounds which includes a pressure bladder, e.g., ablood pressure cuff, disposed proximate a reservoir holding a cleaningsolution. The device in the '104 patent also includes a flexible tubularconduit for transmitting the solution from the reservoir to a singlenozzle. The conduit and reservoir form a two-part system which is timeconsuming to set up, inconvenient to use, and costly.

U.S. Pat. No. 5,133,701 describes a disposable pressurized woundirrigation device which has a pressurized chamber for providing a forceupon the reservoir such that a single liquid stream of cleansingsolution is expelled from the device at a constant pressure. Apropellant is used in evacuating the cleanser contents of the device.This invention requires a propellant and involves a relatively elaboratemanufacturing and filling process which is labor intensive and requiresspecialized machinery. This device is also inconvenient to use andcostly.

The subject invention successfully addresses the above describeddisadvantages associated with the previously known devices and methods,and provides certain attributes and advantages which have not beenrealized by these known devices.

BRIEF SUMMARY OF THE INVENTION

The subject invention concerns a novel and inexpensive method and devicefor convenient and effective manual wound irrigation. In one embodimentthe subject invention provides a discharge means for a standardreservoir housing containing an adequate volume of irrigation solutionwherein the discharge means has a plurality of nozzles through which theirrigation solution can pass. In a preferred embodiment the reservoirhousing, upon which the discharge means is affixed, is compressible orsqueezable (e.g., plastic bottles in which the saline solutions arepresently available). The medical or health care professional or otherperson using the subject device and providing wound irrigation therapycan compress the reservoir housing to force the irrigation solutionthrough the nozzles under sufficient pressure to dislodge dirt, debris,or other particles, including microorganisms, e.g., pathogenic bacteria.

In another embodiment, elongated ports are used to achieve the desireddispersal of the stream of irrigation solution.

The object of the subject invention is to provide an easy to use,economical wound irrigation method and device which are capable ofdelivering adequate volumes of irrigation solution (without refillingthe reservoir) in a dispersed stream under sufficient pressure toeffectively cleanse the wound thereby reducing the incidence ofinfection.

The subject invention would allow the medical professional to, withoutassistance, easily direct and control the application of irrigationsolution with one hand, leaving the other hand free for other activitiessuch as separation of the wound to further facilitate irrigation.

BRIEF SUMMARY OF THE FIGURES

FIG. 1 shows the subject wound irrigation device which includes acompressible reservoir housing, and a discharge means which has aplurality of ports which form nozzles for directing pressurized streamsor a shower of irrigation solution to the wound.

FIG. 2 shows a sectional view of the discharge means illustrating thecone shaped design of the ports forming the nozzles which direct apressurized stream of irrigation solution.

FIG. 3 shows an embodiment of the subject reservoir housing havingincorporated therein an inlet port 6 for supplying pressurized gas froma source 7 to the reservoir 1. The inlet port can be part of a fittingfor affixing thereto a delivery tube 8, which thereby delivers thepressurized gas to the reservoir from the pressurized gas source.

FIG. 4 shows the embodiment of the device comprising a discharge meansand reservoir housing, which includes a back-splash protective shieldcomponent.

DETAILED DESCRIPTION OF THE INVENTION

The subject invention, is a novel convenient, inexpensive and effectivedevice which comprises, in a preferred embodiment, a reservoir housingand a discharge means for irrigation of a wound. The subject inventionalso includes a method of use for the device. The materials and methodsof the subject invention make it possible, for the first time, toconveniently and easily apply a stream of wound irrigation fluid to awound with the stream having an appropriate volume, pressure, anddispersal pattern. Unlike previous attempts to provide wound irrigationdevices, the current invention is particularly advantageous in itssimplicity and its ability to provide a physician with excellent controlover the irrigation process. Under optimal circumstances, the devicesand methods of the subject invention will be utilized by trainedemergency technicians; however, because of the simplicity andconvenience of the subject invention, it can be used to greatly enhancethe effectiveness of wound irrigation regardless of the training levelof the person performing the irrigation.

The subject invention is perhaps best understood by reference to theaccompanying figures. FIG. 1 shows an embodiment of the subjectinvention wherein the device comprises a squeezable reservoir housinghaving a wall 1 which forms a reservoir which can contain therein awound-cleaning material. The reservoir can preferably hold a liquidsolution (e.g., sterile saline) as the wound cleansing solution forirrigating, and thereby removing particles or other contaminants from, awound. The reservoir housing has a mouth or opening which communicatesthe reservoir to the outside of the housing. Disposed over the reservoirhousing opening, and affixed to the reservoir housing is a dischargemeans 2. In one embodiment, the discharge means has a plurality of ports3, each port forming a circular nozzle whereby the irrigation solutionin the reservoir passes through in a pressurized and directional manner.As described herein, other embodiments of the subject invention utilizeslits or combinations of slits and circular ports to achieve theadvantageous fluid dispersion which is critical to the subjectinvention. As used herein, the term nozzle refers to either circularports or elongated ports such as slits. As described herein, a criticalfeature of the subject invention is the unique use of these nozzles toeasily and conveniently achieve a stream of irrigation solution havingthe appropriate volume, pressure and dispersal pattern to obtaineffective wound irrigation which can greatly enhance the safe and speedyrecovery from wounds.

As used herein, reference to a “dispersed” stream of solution means thatthe area from which the stream emanates, or the area which it contacts,is larger than that which can be achieved using a syringe. In oneembodiment, the dispersed stream can be achieved using multiple ports.The ports can be presented in a variety of patterns such as a circularpattern. Alternatively, the dispersed stream can be achieved using anelongated port, such as a slit. The use of slits can also take advantageof a variety of patterns including slits which from arcs or slits whichcross to form an “X” shape or asterisk shape. Combination of slits andcircular ports can also be used.

A removable protective shield 4, which is disposable or reattachable canbe included, if desired, to cap and protect the discharge means and thecontents of the reservoir housing.

The discharge means is a particularly advantageous embodiment of theinvention. The discharge means can be affixed to the reservoir housing.The discharge means can be, for example, a flat or domed disc ofapproximately the same size as the opening of the reservoir housing. Inone embodiment, the discharge means can have a plurality of portstherethrough, each port forming a separate nozzle which allows thecontents of the reservoir to pass directly through during use of theinvention. Each of the ports can be of any desirable size, preferablyless than one-eighth inch in diameter and having a size between about a10 gauge hypodermic needle and about a 30 gauge needle, and mostpreferably having a size ranging from that of a 16 gauge needle to a 25gauge needle. Each of the nozzle-forming ports can be the same size orthe ports can be different sizes and shapes. The different sizes ofports allow for the liquid to be expelled from the discharge means atdifferent pressures. For example, the 16 gauge port allows for a streamhaving about 6 psi pressure when the device is squeezed by the normaladult; the 25 gauge port provides a pressure of up to about 20 psi fromeach nozzle.

In a preferred embodiment, each port is cone-shaped, forming a nozzletraversing the discharge means. The nozzle has a larger diameter on theinner face of the discharge means and a smaller diameter on the outsideface of the discharge means. This embodiment of cone-shaped ports isshown as 5 in FIG. 2. In one embodiment, the wall of the cone-shapednozzle is formed at an angle of about 60 degrees from the perpendicular.Advantageously, the cone shape of each nozzle allows for hydrostaticpressure to keep the nozzle filled with liquid thus lubricating thesurface of the device in the unlikely event that the wound isinadvertently contacted with the discharge means during the irrigationprocess. Alternatively, the ports can be cylindrical instead of coneshaped.

The nozzles can also be formed in different configurations in order tooptimize the irrigation action for particularly desired results. Forexample, one nozzle design comprises a 19 gauge (needle size) centralnozzle surrounded by a circularly disposed row wherein the circle formedby the row of nozzles has a diameter of about 1 cm. The circularlydisposed row consists of about eight (8) nozzles in one embodiment ofthe invention, which are spaced evenly apart from one another. At leasttwo, and preferably four, of these nozzles, alternatingly configured,are formed in such a way that the stream of liquid expelled from thedischarge means is directed at an angle of 45-85 degrees from thesurface of the discharge means. The angle of these ports is preferablybetween 75 degrees and 85 degrees and is most preferably about 82degrees from the surface of the discharge means. The remainder of thenozzles, including the center nozzle, direct a stream at about a90-degree angle from the top surface. The preferred configuration allowsthe stream from each of the nozzles angled at 82 degrees to intersectwith the stream from the center nozzle at about 25 cm from the outersurface of the discharge means.

In another embodiment, the discharge means can include decreased nozzlesize which can generate a greater stream pressure (22 gauge needlesize). This embodiment preferably includes at least one additionalcircularly disposed row either outside or inside the circularly disposedrow as described for the embodiment above. The circularly disposed rowsform nozzles which are disposed in a configuration of concentric rings.An additional circularly disposed row of nozzles can increase the volumeof irrigation solution used in the irrigation process. Alternatively,increasing the diameter of the nozzles can allow greater volume ofirrigation solution to be directed at the wound. Preferably, theadditional circularly disposed row is an outer row which comprises eight(8) additional nozzles approximately 1 cm outward, radially, from thecenter nozzle. The number of nozzles can vary from as little as 2 to asmany as 24 or more as desired. Most preferably at least two, andtypically four, of the nozzles in the outer row, in an alternatingbasis, would direct a stream of the solution contained therein at anangle of about 75 to 85 degrees when discharged by pressure created bysqueezing of the bottle. As would be appreciated by one skilled in theart having the benefit of this disclosure, elongated ports (slits) canbe used to achieve essentially the same dispersal pattern as that whichis produced using the holes as discussed herein.

One embodiment of the subject invention also includes a removable orpartially detachable protective shield, which is placed over thedischarge means to protect the ports and contents of the reservoir fromcontamination or premature discharge or leakage. The protective shieldcan comprise a screw-cap which threadably engages the neck of adischarge means, a snap-on cap which is detachably affixed to thedischarge means or neck of the reservoir housing using a latch, hook, orother locking or connecting means, or a hinged cover commonly referredto as a “flip-top” cap. The hinged cover can be permanently affixed tothe discharge means or can be part of a threadably engaged screw-cap orprotective shield.

A second type of protective shield can also be provided as a componentof the subject device. This second type of protective shield is a“back-splash” protective shield wherein the back-splash protectiveshield is detachably or permanently affixed to the device, preferablybetween the discharge means and the compressible reservoir housing. Theback-splash protective shield protects the health care professional fromback-splash of human and or animal body fluids which are mixed with andsplashed from the wound when the wound is contacted by the dischargedirrigation solution.

The wall of the reservoir housing can be made or molded from anymaterial which is preferably rigid enough to stand upright when thereservoir is filled with irrigation solution. In a typical embodiment,the reservoir housing is formed by a molded plastic which is pliableenough so that the wall of the reservoir housing can be squeezed orcompressed by hand to exert pressure on the contents of the reservoir.Other materials can also be used for the reservoir housing walls,including rubber, laminated or plastic-lined paper, a compositematerial, or the like, as would be readily understood in the art. Thesematerials are commercially available. The preferred embodiment comprisesa plastic material which is pliable enough to squeeze by hand and whichalso has resilience properties to return to its original shape when nolonger compressed or squeezed.

The horizontal cross-sectional shape of the reservoir housing can besquare, rectangular, cylindrical, or other geometric shapes as desiredor as already available. The walls can be tapering toward one end or theother. Alternatively, other shapes can be made for the reservoir housingaccording to and adapted for a particular use. For example, part of thereservoir housing wall can be slightly rounded as in a general hourglassshape or can be molded according to ergonomic consideration for easilyfitting a hand or otherwise facilitating handling or compressing thereservoir housing. The reservoir formed by the housing of the subjectinvention can typically hold a volume of about 100 ml to 1000 ml,preferably about 250 ml to about 750 ml and most preferably about 500ml.

Further, in a preferred embodiment, the reservoir housing comprises atone end a mouth and a neck portion formed at the mouth end. The neckportion of the reservoir housing is generally at least slightly smallerin diameter than the diameter or diagonal measurement of the reservoirhousing. The neck of the reservoir housing forms a connecting means,e.g., threads, for affixing the discharge means thereto. The reservoirhousing neck is preferably integrally molded with the reservoir housing,but can be formed or molded separately and affixed to the mouth end ofthe reservoir housing. The material used for the neck portion of thereservoir housing can be the same as the material used to make thereservoir housing cylinder.

Alternatively, the neck portion can be a different material, forexample, a more rigid or sturdy material than the compressible materialforming the reservoir housing wall. For example, the material used tomake the neck portion can be a metal or a hard plastic, or the like.

The neck portion can be formed having threads, or latches, or otherconnecting means for affixing the discharge means thereto. Theconnecting means can be on the outer face of the neck portion, forming amale connecting end, or can be on the inner face forming a femaleconnecting end of the neck portion.

The discharge means can have connecting means complementary andattachable to the neck portion. In a preferred embodiment, the neckportion and discharge means can have threads or grooves so that thedischarge means can be detachably and/or threadably engaged to the neckportion of the reservoir housing. This screw-top design can be made tobe adaptable to available irrigation solution bottles. Thus, thedischarge means of the subject invention is interchangeable, whendesired, with the screw-cap which is provided with an irrigationsolution bottle as are available. The screw-top design provides the userwith the option of using the reservoir housing with the nozzle-formingports or to threadably remove the discharge means and pour out or changethe irrigation solution.

Another embodiment of the discharge means includes a stopper which canbe forced or wedged into the mouth of a reservoir housing. The stoppercan have a flange which facilitates positioning of the stopper bypreventing its insertion completely through the opening of the reservoirhousing and into the reservoir. In another embodiment, the dischargemeans can be affixed directly to the reservoir housing or neck portionof the reservoir housing so that the discharge means fits flush with themouth of the reservoir housing. This flush-fitting embodiment of thedischarge means is formed as an integral part of the reservoir housingwherein the discharge means is molded with, or heat-sealed to, thereservoir housing. An alternative embodiment is a flush-fittingdischarge means which is held in place over the mouth of the reservoirhousing with a connecting ring threadably engaging the threaded neck ofthe reservoir housing. The discharge means is held in place by having arib or groove which corresponds to and engages a groove or flange on thethreaded connecting ring.

Another embodiment of the subject invention includes a reservoir housingcomprising an inlet port and fitting for attaching a flexible tubing fordelivery of pressurized gas to the reservoir. A pressurized irrigationreservoir would employ an embodiment of a squeezable reservoir housingthat can be attached to an outside pressure source. Pressure sourcesgenerally available in hospitals, emergency rooms, and other medicalclinics or facilities provide a pressure of 0-55 pounds per square inch(PSI). The reservoir would attach via a flexible tube to the pressuresource connector and to the fitting provided on the reservoir housing ofthe subject device. Supplying to the reservoir an outside source ofpressurized gas would permit the medical professional to discharge theirrigation solution obtained in the reservoir at a constant pressure. Avalve can also be incorporated into the inlet port fitting, thereservoir housing, and/or the discharge means to stop the flow of airpressurizing the reservoir or to stop the flow of irrigation solutiondischarged from the discharged means. This permits interruption of thewound irrigation process, and thus control, by the user as desired.Alternatively, the reservoir could itself be pressurized so that noexternal pressure source is necessary. In this embodiment, the reservoircould be manufactured to contain a pressurized gas to expel theirrigation fluid with the desired force. The pressurized gas could beseparated from the fluid by, for example, a diaphragm.

The irrigation solution used can be water, saline, or a balanced saltsolution. The solution is preferably sterile and at the discretion ofthe user or manufacturer of the irrigation solution can additionallycomprise an antibacterial and/or antifungal component. The device can besterilized by known sterilization techniques, including boiling,autoclaving, gas sterilization and the like, either separately ortogether with the reservoir housing.

Buffered Ringer's solution or commercially available balanced saltsolution (e.g., Tis-U-Sol or Physio-Sol) are physiologically compatibleand are commonly used in wound irrigation procedures.

The antiseptic agents most commonly used in wound care at presentinclude:

Povidone-iodine solution (Betadine preparation)-iodine added to thecarrier polyvinylpyrrolidone(PVP), a water-soluble organic complex; thiscombination is called an iodophor. Standard solutions of Betadinepreparation are 10 per cent.

Povidone-iodine surgical scrub (Betadine scrub)-the iodophor PVP-I andan anionic detergent (pH 4.5).

pHisoHex-an emulsion of an anionic detergent, entsulfon, lanolincholesterols, petrolatum, and hexachiorophene (pH 5.5).

Hi-Bi-clens-chlorhexidine gluconate plus a sudsing base (pH 5.1 to 6.5).

Tincture of green soap-potassium oleate, isopropanol, potassium coconutoil, soap.

Dakin's solution 0.2 per cent solution hypochlorite solution.

Hydrogen peroxide-an oxidizing agent.

Benzalkonium chloride (Zephiran)-a quaternary ammonium compound thatworks as a cationic surface active agent.

Nonionic surfactants-Pluronic F-68 (Shur-Clens) and Poloxamer-188(Pharma Clens)-agents that have no antimicrobial activity (pH 7.1).

From the description of the device hereinabove, a method of using thesubject device would readily be understood and adaptable by thosepersons having ordinary skill in the art. The reservoir housing isfilled with a desired irrigation solution. The irrigation solution issterilized before or after filling. The reservoir housing and contentscan be stored in a sterile environment, e.g., sterile packaging which isopened immediately prior to use. In a preferred use, the protectiveshield is removed, then the reservoir housing can be directed towardsthe wound and squeezed or compressed to expel or discharge the solutionin the desired direction, and at the desired pressure to effectirrigation of a wound to remove contaminants or debris. See also theExample, provided below.

It would also be understood that the described discharge means can bepackaged separately from the reservoir housing. The discharge means ispackaged in a sterile environment. In a preferred use of the embodimentwherein the discharge means is provided separately from the reservoirhousing, the cap of a readily available, squeezable irrigation bottlecontaining a sterile irrigation solution, e.g., normal saline, isreplaced with the subject discharge means. The bottle, now having thesubject discharge means attached or engaged thereto, can be used asdescribed herein.

Significantly, it is known that more force is required to rid the woundof particles with a small surface area (e.g., bacteria) than to removeparticles with a large surface area (e.g., dirt, sand, or vegetation).Minimum recommended volumes of irrigation solution vary, but for amoderately sized potentially contaminated wound, for example alaceration 3-6 cm long and less than 2 cm deep, 200 to 300 ml should beused. Greater volumes, on the order of one to two liters, may berequired for larger or heavily contaminated wounds. Irrigation shouldcontinue at least until all visible, loose particulate matter has beenremoved.

Following is an example which illustrates procedures, including the bestmode, for practicing the invention. This example should not be construedas limiting. All percentages are by weight and all solvent mixtureproportions are by volume unless otherwise noted.

EXAMPLE 1 METHODS OF WOUND IRRIGATION

When a patient presents a wound to a medical or other health careprofessional skilled in the art, that medical professional assesses theextent of the injury sustained by the patient, including all other lifethreatening injuries. Appropriate action regarding these lifethreatening injuries is performed and a history is recorded. All woundsare covered to minimize further contamination until the actual repairprocess begins.

For examination of the wound, it is assumed that a medical professionalwould have performed a detailed evaluation of the extent of tissueinjury, including but not limited to: anatomical area considerations,depth of the wound, type of injury, e.g., crush injury, puncture wound,bites, missiles, cuts with sharp objects, or the like. Included in thisexamination would be a determination of the type(s) of contamination,time elapsed between the occurrence of the injury to presentation, grosscontamination of a wound, and other medical factors associated with anincrease incidence of infection (for example, diabetics, AIDS patients,and chemotherapeutics patients).

The wound and surrounding tissue, at the option of the health careprofessional, could be anesthetized using topical, local, or generalanesthetics before the wound-cleansing method begins.

In one embodiment, the subject device has a discharge means affixed to areservoir housing as described with a protective shield covering thedischarge means. The health care professional using the subject devicewould remove the protective shield to expose the discharge means. Thesubject device can be held in either hand as preferred by the user.Normally, it would be held in the dominate hand in a bottle-holdingfashion. This allows the medical care professional to gently open thewound if needed, with the opposite hand, preferably protected by asterile glove, to expose the depths of the wound.

Once the depths of the wound have been exposed, the end of the reservoirhousing having the discharge means affixed thereto is directed towardsthe wound. Manual or mechanically produced pressure is applied to thereservoir housing to expel the irrigation solution through the nozzlesof the discharge means. The wound should be irrigated in this fashionuntil all visible evidence of contamination has been removed. Apotentially contaminated wound of any size should be irrigated with aminimum of 200-300 ml of irrigation solution. Heavily contaminated orlarger wounds may require 2-3 liters of irrigation solution. The healthcare professional could vary the angle of the discharged irrigationsolution from the discharge means in reference to the wound to furtherassist with the dislodgement of contaminants. This variation in theangle will also decrease or increase the amount of back-splash. Thus itwould be important to irrigate in a manner that decreases theback-splash. Minimizing back-splash is achieved by irrigation at acuteangles to the plane of the wound.

Following an initial irrigation of the wound, a re-examination of thewound should be undertaken. The wound should be explored to its base toascertain that no visible foreign bodies or contaminants remain. Ifforeign bodies or contaminants are found, the irrigation process shouldbe repeated followed by a re-examination. This may continue for severalcycles.

Once irrigation has been completed, i.e., no visible contaminantsremain, the would be repaired in a standard accepted fashion.

It should be understood that the example and embodiment described hereinis for illustrative purposes only and that various modifications orchanges in light thereof will be suggested to persons skilled in the artand are to be included within the spirit and purview of this applicationand the scope of the appended claims.

What is claimed is:
 1. A method for irrigating a wound, said methodcomprising the following steps: (a) providing a sterile wound-irrigationsolution in a compressible or pressurized reservoir housing having adischarge means comprising a plurality of ports therethrough whereinsaid each port forms a nozzle for directing a pressurized stream of saidsolution, and wherein the shape and configuration of said ports, resultsin a dispersed stream of said solution; (b) directing the dischargemeans and reservoir housing so as to discharge the wound-irrigationsolution toward said wound; and (c) discharging said wound-irrigationsolution from said reservoir housing and through said nozzles, toproduce a dispersed stream of said wound-irrigation solution directed atsaid wound, wherein said dispersed stream is applied with sufficientforce to dislodge contaminants and wherein the area from which saidstream emanates, or the area which it contacts, is larger than thatwhich can be achieved using a syringe thereby effectively irrigatingsaid wound.
 2. The method, according to claim 1, wherein saidwound-irrigation solution is discharged from said port, or ports, at apressure between about 6 PSI and about 20 PSI.
 3. The method, accordingto claim 1, wherein said ports are circular apertures and the diameterof said circular apertures is between that of a 10 gauge hypodermicneedle and a 30 guage hypodermic needle.
 4. The method, according toclaim 3, wherein said ports are circular apertures and the diameter ofsaid circular apertures is between that of a 10 gauge hypodermic needleand a 30 gauge hypodermic needle.
 5. The method, according to claim 4,wherein the diameter of said circular apertures is between that of a 16gauge hypodermic needle and a 25 gauge hypodermic needle.
 6. The method,according to claim 3, wherein said ports are circular apertures with adiameter of less then about ⅛ inch.
 7. The method, according to claim 1,wherein said ports are conical in shape through said aperture.
 8. Themethod, according to claim 1, wherein said discharge means comprises atleast one elongated port.
 9. The method, according to claim 1, whereinsaid discharge means is detachably engaged to said reservoir housing.10. The method, according to claim 1, wherein said discharge meanscomprises a protective shield.
 11. The method, according to claim 10,wherein said protective shield is detachable.